For the Consumer

In addition to its needed effects, some unwanted effects may be caused by adalimumab. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking adalimumab:

More common:

Body aches or pain

chills

cough

diarrhea

difficulty with breathing

ear congestion

fever

general feeling of discomfort or illness

headache

joint pain

loss of appetite

loss of voice

muscle aches and pains

nausea

pain or tenderness around the eyes and cheekbones

shivering

sneezing

sore throat

stuffy or runny nose

sweating

tightness of the chest or trouble breathing

trouble sleeping

unusual tiredness or weakness

vomiting

Less common:

Abdominal or stomach pain

bleeding from the gums or nose

bloating or swelling of the face, arms, hands, lower legs, or feet

chest pain

dizziness

eye pain

fainting

fast, slow, or irregular heartbeat

general feeling of tiredness or weakness

hoarseness

lower back or side pain

painful or difficult urination

rapid weight gain

ringing in the ears

sores, ulcers, or white spots on the lips or in the mouth

tingling of the hands or feet

unusual bleeding or bruising

unusual weight gain or loss

Incidence not known:

Blindness

blistering, peeling, loosening of the skin

blue-yellow color blindness

blurred vision

dark-colored urine

decreased vision

diarrhea

eye pain

general feeling of tiredness or weakness

itching

joint or muscle pain

light-colored stools

red skin lesions, often with a purple center

red, irritated eyes

red, scaling, or crusted skin

stomach pain, continuing

yellow eyes or skin

Minor Side Effects

Some of the side effects that can occur with adalimumab may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Most of the tuberculosis cases occurred within the first 8 months of therapy and included miliary, lymphatic, peritoneal, and pulmonary types. Opportunistic infections were due to histoplasma, aspergillus, and nocardia.[Ref]

During the controlled portions of adalimumab trials in patients with moderately to severely active rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, malignancies (other than lymphoma and non-melanoma skin cancer) were observed at a rate of 0.7 per 100 patient-years among adalimumab-treated patients versus a rate of 0.3 per 100 patient-years among control patients. The median duration of treatment was 5.7 months for adalimumab-treated patients and 5.5 months for control-treated patients.

During the controlled portions of adalimumab rheumatoid arthritis trials, the rate of non-melanoma skin cancers was 0.9 per 100 patient-years among adalimumab-treated patients and 0.2 per 100 patient-years among control patients.

More cases of malignancies have been observed among patients receiving TNF blockers, including adalimumab, compared to controls. Patients with rheumatoid arthritis, particularly those with highly active disease, are at a higher risk for the development of lymphoma.

A meta-analysis has reported that there is dose-dependent increased risk of malignancies in patients with rheumatoid arthritis treated with anti-TNF antibody therapy.[Ref]

Immunologic

Positive ANA titers were observed at week 24 in 12% of patients (vs 7% with placebo). One patient (0.04%) developed symptoms of new-onset lupus-like syndrome and recovered after discontinuation of adalimumab.

Low-titer antibodies to adalimumab have been observed at least once during treatment in 5% of patients (n=1062). Antibodies developed in 12% of patients on adalimumab monotherapy and in 1% of patients on concurrent methotrexate. During monotherapy, the ACR20 (American College of Rheumatology criteria) response was lower in antibody-positive patients.

A meta-analysis has reported that there is evidence of an increased risk of serious infections in patients with rheumatoid arthritis treated with anti-TNF antibody therapy.[Ref]

Common (1% to 10%): Flu syndromeUncommon (0.1% to 1%): SarcoidosisFrequency not reported: Development of autoantibodies[Ref]

Cardiovascular

Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers, including adalimumab. In clinical studies of another TNF blocker, a higher rate of serious CHF-related adverse events was observed.[Ref]

Professional resources

Related treatment guides

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